Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a mechanical valve with programmable settings adjusted by magnetic force, with no mention of AI or ML.

Therapeutic

Yes

The device is designed to treat hydrocephalus by diverting cerebrospinal fluid to relieve intracranial pressure, thus providing a therapeutic function.

Diagnostic

No

This device is designed to manage hydrocephalus by diverting CSF and regulating intraventricular pressure, which are therapeutic functions, not diagnostic ones. It does not identify a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "implantable device" and describes physical components and testing related to hardware (e.g., functional testing, MRI testing, X-Ray testing, biocompatibility testing).

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
Device Description: The Certas Plus Programmable Valve is an implantable device that is surgically placed inside the body to manage hydrocephalus by draining CSF.
Intended Use: Its purpose is to directly treat a condition within the body, not to analyze samples taken from the body.

Therefore, based on the provided information, the Certas Plus Programmable Valve is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Product codes

JXG

Device Description

The Certas Plus Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Certas Plus Programmable Valve, to another body cavity where it is subsequently absorbed. The Certas Plus Programmable Valves can be set to eight different performance settings for intraventricular pressure and drainage of CSF. The performance settings of the valves can be set preoperatively and can also be noninvasively changed postimplantation by using the Certas Tool Kits. The Certas Tool Kits employ magnetic force to select one of eight settings.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The following performance testing has been conducted in support of the substantial equivalence determination. The testing utilized well-established methods, including those from FDA consensus standards. All testing was performed on production equivalent devices.

Performance Bench Test Results:

Accelerated Aging for Shelf Life Testing per ASTM F1980: Pass
Functional Testing per ISO 7197: Pass
Functional Testing per ASTM F647: Pass
MRI Testing per ISO/TS 10974: Pass
X-Ray Testing per ASTM F640: Pass

Biocompatibility Testing Results:

MTS Cytotoxicity per ISO 10993-5: Pass
Guinea Pig Maximization Sensitization Study per ISO 10993-10: Pass
Intracutaneous Irritation Study in Rabbits per ISO 10993-10: Pass
Acute Systemic Toxicity Study in mice per ISO 10993-11: Pass
Rabbit Pyrogen Study per United States Pharmacopeia 42 – NF 37: Pass
Subcutaneous Implantation Studies in Rabbits, 1 and 4 weeks per ISO 10993-6: Pass
Systemic Toxicity and Local Effects Study in Rabbits following Subcutaneous Implantation 13 weeks per ISO 10993-6 and ISO 10993-11: Pass
Bacterial Reverse Mutation Study per ISO 10993-3 and ISO/TR 10993-33: Pass
In Vitro Mouse Lymphoma Study per ISO 10993-3 and ISO/TR 10993-33: Pass
Hemolysis on Extract Study per ISO 10993-4 and ASTM F756: Pass

No clinical studies were required as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of testing.

Key Metrics

Not Found

Predicate Device(s)

Certas Plus Programmable Valves: K152152 and K182265

Reference Device(s)

Certas Plus Programmable Valves: K143111

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 1, 2023

Integra LifeSciences Production Corporation Amanda Erwin Manager, Regulatory Affairs 11 Cabot Boulevard Mansfield, Massachusetts 02048

Re: K223330

Trade/Device Name: Certas Plus Programmable Valves Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: October 31, 2022 Received: November 3, 2022

Dear Amanda Erwin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature includes the name "Adam D. Pierce -S" on two lines. The signature also includes the date "2023.02.01" and the time "11:59:50-05'00'".

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223330

Device Name Certas Plus Programmable Valves

Indications for Use (Describe)

The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

807.92(a) (1) Submitter Information
Name and Address	Integra LifeSciences Production Corporation
11 Cabot Boulevard
Mansfield, MA 02048

Certas Plus Programmable Valves: K143111 (reference device) |
| 807.92(a) (4) Device Description | |

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The Certas Plus Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Certas Plus Programmable Valve, to another body cavity where it is subsequently absorbed. The Certas Plus Programmable Valves can be set to eight different performance settings for intraventricular pressure and drainage of CSF. The performance settings of the valves can be set preoperatively and can also be noninvasively changed postimplantation by using the Certas Tool Kits. The Certas Tool Kits employ magnetic force to select one of eight settings.

807.92(a) (5) Indications for Use

The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

807.92(a) (6) Technological Characteristics Compared to Predicate

The proposed Certas Plus Programmable Valves have intended use, sterility, design principles and fundamental operation as the predicate valves. The proposed minor change in technological characteristics for the valves consists of a material change and minor dimensional and tolerance changes for various components. The changes do not raise any new questions of safety and/or effectiveness.

Component Affected	Proposed Modification	Rationale
Various Internal
Components	Replacement of
Polyethersulfone
(PES) with
Polysulfone (PSU) in
Certas Plus
Programmable
Valves for various
internal components.	Polyethersulfone will
no longer be available
for Integra to
manufacture the
impacted internal
components with.
	Replacement of
Nylon with	Nylon will no longer
be used to
	Polysulfone (PSU) in
Certas Plus
programmable Valve
Needle Guard internal
component.	manufacture the
impacted Certas Plus
Programmable Valve
Inline Valve Needle
Guard internal
component with.
	Minor dimensional
and tolerance changes
to internal
components. A
design feature in the
Small and Right
Angle Needle Guards
will also be removed.	The minor
dimensional and
tolerance changes to
the internal
components have
been made to
accommodate the
material changes. The
removal of the design
feature in the Small
and Right Angle
Needle Guards was
done to remove a
design feature that
was never utilized.
Labeling	Updates made to
reflect the proposed
material changes, as
well as administrative
updates and
corrections.	Update labelling with
new material and
administrative
updates and corrected
information.
	Inclusion of a Patient
Implant Card and a
Patient Information
Leaflet	A Patient Implant
Card and Patient
Information Leaflet is
included as the
devices are MR
conditional implants.
807.92(b) 1-2: Summary of Nonclinical and Clinical Testing Performed

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The following performance testing has been conducted in support of the substantial equivalence determination. The testing utilized well-established methods, including those from FDA consensus standards. All testing was performed on production equivalent devices.

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Performance Bench Test Results
Test	Conclusion
Accelerated Aging for Shelf Life Testing per
ASTM F1980	Pass
Functional Testing per ISO 7197	Pass
Functional Testing per ASTM F647	Pass
MRI Testing per ISO/TS 10974	Pass
X-Ray Testing per ASTM F640	Pass

Biocompatibility Testing Results
Test	Conclusion
MTS Cytotoxicity per ISO 10993-5	Pass
Guinea Pig Maximization Sensitization Study per
ISO 10993-10	Pass
Intracutaneous Irritation Study in Rabbits per ISO
10993-10	Pass
Acute Systemic Toxicity Study in mice per ISO
10993-11	Pass
Rabbit Pyrogen Study per United States
Pharmacopeia 42 – NF 37	Pass
Subcutaneous Implantation Studies in Rabbits, 1
and 4 weeks per ISO 10993-6	Pass
Systemic Toxicity and Local Effects Study in
Rabbits following Subcutaneous Implantation 13
weeks per ISO 10993-6 and ISO 10993-11	Pass
Bacterial Reverse Mutation Study per ISO 10993-3
and ISO/TR 10993-33	Pass
In Vitro Mouse Lymphoma Study per ISO 10993-3
and ISO/TR 10993-33	Pass
Hemolysis on Extract Study per ISO 10993-4 and
ASTM F756	Pass

There are no changes in sterility as a result of the proposed material changes and minor dimensional and tolerance changes; a sterilization equivalency assessment was performed comparing the proposed device to the predicate device and deemed acceptable.

No clinical studies were required as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of testing.

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807.92(b) (3) Conclusion

Based upon the intended use, design, comparison to the predicate device, and testing performed, Integra LifeSciences believes that the proposed modifications to the Certas Plus Programmable Valves do not raise any new questions of safety and effectiveness, and is therefore, substantially equivalent to the predicate Certas Plus Programmable Valves.